FDA Recall: ByHeart Whole Nutrition Infant formula
Source: FDA
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FDA Recall: ByHeart Whole Nutrition Infant formula

ByHeart • November 20, 2025

2025 ByHeart Infant Formula Recall: Complete Batch List & Botulism Risk Explained

Safety Alert: ByHeart has recalled every batch of its Whole Nutrition Infant Formula—both 24 oz cans and 0.6 oz single-serve packets—after routine environmental testing flagged possible Clostridium botulinum contamination. Parents and caregivers should stop using the formula immediately, verify product lots, and follow the steps below for refunds or replacements.

Why Did ByHeart Issue a Nationwide Recall?

On November 11, 2025, ByHeart, Inc. voluntarily notified the U.S. Food and Drug Administration (FDA) that environmental samples collected at a third-party manufacturing facility tested positive for Clostridium botulinum. While no finished product tested positive and no illnesses have been reported to date, the company opted to recall all batches out of an abundance of caution to protect infants from a potential botulism risk.

Affected ByHeart Infant Formula Products (All Lot Codes)

  • ByHeart Whole Nutrition Infant Formula, 24 oz metal cans
  • ByHeart Whole Nutrition Infant Formula, 0.6 oz single-serve packets
  • All production lots, manufacturing dates, and expiration (“best by”) dates

Botulism Symptoms in Infants: What to Watch For

Clostridium botulinum produces a toxin that can cause life-threatening botulism, particularly in babies under 12 months. Seek emergency medical care if an infant shows any of the following symptoms after ingesting the recalled formula:

  • Constipation or poor feeding
  • Weak cry or decreased movement
  • Difficulty breathing
  • Lethargy, floppiness, or muscle weakness

Immediate Steps for Parents and Caregivers

  1. Stop feeding ByHeart Whole Nutrition Infant Formula to your child.
  2. Verify the package—all codes, lots, and “best by” dates are included in the recall.
  3. Visit ByHeart’s recall page or contact customer service for refund or replacement instructions.
  4. Dispose of the product safely or store it in a sealed container until you receive return guidance.

View Official FDA Recall Announcement

Sources

FAQ: ByHeart Infant Formula Recall 2025

Frequently Asked Questions

Why is ByHeart recalling its infant formula products?
Environmental testing at a third-party facility detected potential Clostridium botulinum, prompting a precautionary, nationwide recall to protect infants from botulism.
Which ByHeart Whole Nutrition Infant Formula batches are included in the recall?
Every lot code and expiration date of ByHeart Whole Nutrition Infant Formula in 24 oz cans and 0.6 oz packets is affected.
Have any infants become sick from ByHeart Infant Formula?
No illnesses or adverse events were reported as of the FDA’s November 19, 2025 update.
What symptoms indicate possible botulism from ByHeart Infant Formula?
Watch for constipation, weak cry, poor feeding, muscle weakness, or breathing difficulties—seek immediate medical attention if any appear.
How do I claim a refund or replacement for recalled ByHeart Infant Formula?
Use the contact details in the FDA recall notice or on ByHeart’s website; the company is providing full refunds or product replacements.
Is it safe to use unopened cans of ByHeart Infant Formula with future expiration dates?
No. All unopened and opened cans or packets—regardless of expiration date—are part of the recall and should not be used.
What alternatives can parents use while ByHeart Infant Formula is unavailable?
Speak with your pediatrician or healthcare provider to choose a suitable replacement formula that meets your baby’s nutritional needs.

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